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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-004857-21 | EudraCT Number | ||
| 63723283HPB1001 | Other Identifier | Janssen Research and Development, LLC |
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The purpose of the study is to characterize the pharmacokinetic (PK) profile of cetrelimab administered subcutaneous (SC) and optionally intravenous (IV) in chronic hepatitis B (CHB) participants.
Hepatitis B virus (HBV) is a small deoxyribonucleic acid (DNA) virus that infects the liver and can cause either acute (less than 6 months) or chronic (more than 6 months) infection. Persistence of HBV infection requires antigen-specific immune tolerance that prevents clearance of infected cells. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin (Ig) G4 kappa monoclonal antibody (mAb) that binds to programmed cell death receptor-1 (PD-1) with high affinity and specificity. PD-(L)1 inhibitors could possibly reverse the immune dysfunction from HBV. The study will be conducted in 3 phases: a screening phase (6 weeks), a single dose intervention phase (1 day), and a 24-week follow-up phase. The duration of individual participation will be up to 30 weeks. Key safety assessments include monitoring of Adverse Events (AEs), physical examination, vital signs, Electrocardiogram (ECGs), Injection site reaction (ISRs), Infusion-related reaction (IRRs), and clinical laboratory tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Cetrelimab or Placebo (Dose 1) | Experimental | Participants will receive cetrelimab Dose 1 or placebo via subcutaneous (SC) injection on Day 1. |
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| Cohort 2 (Optional): Cetrelimab or Placebo (Dose 2) | Experimental | Participants will receive cetrelimab Dose 2 or placebo administered via an Intravenous (IV) infusion on Day 1 based on the data review of previous cohort(s) (safety and tolerability data through at least 6 weeks postdose as well as pharmacokinetic (PK) and receptor occupancy (RO) data through at least day 4 postdose). |
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| Cohort 3 (Optional): Cetrelimab or Placebo | Experimental | Participant will receive cetrelimab or placebo via SC injection based on the data review of previous cohort(s) (safety and tolerability data through at least 6 weeks postdose as well as PK and RO data through at least day 4 postdose). |
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| Cohort 4 (Optional): Cetrelimab or Placebo | Experimental | Participant will receive cetrelimab or placebo via SC injection based on the data review of previous cohorts (safety and tolerability data through at least 6 weeks postdose as well as PK and RO data through at least day 4 postdose). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetrelimab | Drug | Cetrelimab (Dose 1 and Dose 2) will be administered via SC injection or as an IV infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of Cetrelimab | Cmax is defined as maximum observed serum concentration of cetrelimab. | Up to 24 weeks |
| Area Under the Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of Cetrelimab | AUC(0-last) is defined as area under the concentration-time curve from time 0 to the time of the last measurable concentration (non-below quantification limit [non-BQL]) of cetrelimab as calculated by linear-linear trapezoidal summation. | Up to 24 weeks |
| Apparent Terminal Elimination Half-life (t1/2) of Cetrelimab | t1/2 is defined as apparent terminal elimination half-life of cetrelimab. | Up to 24 weeks |
| Total Systemic Clearance of Cetrelimab | Total systemic clearance is a quantitative measure of the rate at which cetrelimab is removed from the body. | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in HBsAg and HBeAg Levels Over Time | Change from baseline in Hepatitis B surface antigen (HBsAg), Hepatitis Be antigen (HBeAg) levels over time will be reported. | Baseline up to 30 weeks |
| Change from Baseline in Hepatitis B Virus Deoxyribonucleic acid (HBV DNA) Levels Over Time |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research and Development, LLC Clinical Trial | Janssen Research and Development LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Belgium NV | Edegem | 2650 | Belgium | |||
| Az Sint-Maarten |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Placebo | Drug | Placebo will be administered via SC injection or as an IV infusion. |
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Change from baseline in HBV DNA levels over time will be reported. |
| Baseline up to 30 weeks |
| Number of Participants with Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. | Up to 30 weeks |
| Cohorts 1,3 and 4: Number of Participants with Injection Site Reaction (ISR) | Number of Participants with ISR will be reported. An ISR is any adverse reaction at a subcutaneous (SC) study intervention injection-site. | Up to 30 weeks |
| Number of Participants with Abnormalities in Clinical Laboratory Tests | Number of participants with abnormalities in clinical laboratory tests (including hematology, serum chemistry and urinalysis) will be reported. | Up to 30 weeks |
| Mechelen |
| 2800 |
| Belgium |
| Hopital Beaujon | Clichy | 92110 | France |
| APHP - Hopital Henri Mondor | Créteil | 94010 | France |
| CHU Grenoble | Grenoble | 38043 | France |
| Hopital Saint-Antoine | Paris | 75571 | France |
| Universitaetsklinikum Essen | Essen | 45147 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| PUNKT ZDROWIA Hlebowicz Jakubowski Lekarze sp.p. | Gdansk | 80405 | Poland |
| ID Clinic | Mysłowice | 41-400 | Poland |
| Hosp. Univ. Marques de Valdecilla | Santander | 39008 | Spain |
| Hosp. Virgen Del Rocio | Seville | 41013 | Spain |
| Hosp. Gral. Univ. Valencia | Valencia | 46014 | Spain |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |